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NCT02048020
Paclitaxel and Carboplatin Before Radiation Therapy With Paclitaxel in Treating HPV-Positive Patients With Stage III-IV Oropharynx, Hypopharynx, or Larynx Cancer
Phase 2 trial testing paclitaxel in Human Papilloma Virus Infection in 26 participants. Completed in 9 January 2017.
9 January 2017
Quick facts
| Lead sponsor | Jonsson Comprehensive Cancer Center |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 26 |
| Start date | 26 December 2013 |
| Primary completion | 9 January 2017 |
| Estimated completion | 9 January 2017 |
| Sites | 1 location across United States |
Drugs / interventions tested
- paclitaxel — full drug profile →
- carboplatin (Carboplatin) — full drug profile →
- intensity-modulated radiation therapy
- quality-of-life assessment
Conditions studied
- Human Papilloma Virus Infection — all drugs for Human Papilloma Virus Infection →
- Stage III Squamous Cell Carcinoma of the Hypopharynx — all drugs for Stage III Squamous Cell Carcinoma of the Hypopharynx →
- Stage III Squamous Cell Carcinoma of the Larynx — all drugs for Stage III Squamous Cell Carcinoma of the Larynx →
- Stage III Squamous Cell Carcinoma of the Oropharynx — all drugs for Stage III Squamous Cell Carcinoma of the Oropharynx →
Sponsor
Jonsson Comprehensive Cancer Center — full company profile →
Who can join
19 and older, any sex, with Human Papilloma Virus Infection or Stage III Squamous Cell Carcinoma of the Hypopharynx. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies how well paclitaxel and carboplatin before radiation therapy with paclitaxel works in treating human papillomavirus (HPV)-positive patients with stage III-IV oropharynx, hypopharynx, or larynx cancer. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x rays to kill tumor cells. Giving paclitaxel and carboplatin before radiation therapy with paclitaxel may kill more tumor cells.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
HPV-associated oropharyngeal cancer: epidemiology, molecular biology and clinical management.
Lechner M, Liu J, Masterson L, Fenton TR. · · 2022 · cited 669× · PMID 35105976 · DOI 10.1038/s41571-022-00603-7 -
Reduced-dose radiotherapy for human papillomavirus-associated squamous-cell carcinoma of the oropharynx: a single-arm, phase 2 study.
Chen AM, Felix C, Wang PC, Hsu S, et al · · 2017 · cited 246× · PMID 28434660 · DOI 10.1016/s1470-2045(17)30246-2 -
An Updated Review on Head and Neck Cancer Treatment with Radiation Therapy.
Anderson G, Ebadi M, Vo K, Novak J, et al · · 2021 · cited 163× · PMID 34638398 · DOI 10.3390/cancers13194912 -
HPV-driven oropharyngeal cancer: current knowledge of molecular biology and mechanisms of carcinogenesis.
Pan C, Issaeva N, Yarbrough WG. · · 2018 · cited 79× · PMID 31093365 · DOI 10.1186/s41199-018-0039-3 -
Deintensification of treatment for human papillomavirus-related oropharyngeal cancer: Current state and future directions.
Bigelow EO, Seiwert TY, Fakhry C. · · 2020 · cited 55× · PMID 32247987 · DOI 10.1016/j.oraloncology.2020.104652 -
Therapeutic strategies of different HPV status in Head and Neck Squamous Cell Carcinoma.
Sun Y, Wang Z, Qiu S, Wang R. · · 2021 · cited 43× · PMID 33867833 · DOI 10.7150/ijbs.58077 -
Patient-reported quality-of-life outcomes after de-escalated chemoradiation for human papillomavirus-positive oropharyngeal carcinoma: Findings from a phase 2 trial.
Hegde JV, Shaverdian N, Shaverdian N, Daly ME, et al · · 2018 · cited 27× · PMID 29044458 · DOI 10.1002/cncr.30954 -
De-Escalation Strategies for Human Papillomavirus-Associated Oropharyngeal Squamous Cell Carcinoma-Where Are We Now?
Silver JA, Turkdogan S, Roy CF, Subramaniam T, et al · · 2022 · cited 19× · PMID 35621685 · DOI 10.3390/curroncol29050295
Verify or expand the search:
- PubMed search for NCT02048020
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02048020 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center
- Last refreshed: 14 August 2018
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